Preparing for Biocompatibility Testing: Strategic Considerations for Medical Device Manufacturers

Biocompatibility testing is essential for every medical device, ensuring safety, regulatory approval, and market success. The process, however, can be complex and time-consuming, requiring thorough preparation. By understanding regulatory expectations and engaging with experts early, manufacturers can transform testing from a compliance hurdle into a strategic advantage.

At the European Biomedical Institute (EBI), we support manufacturers in navigating this process with clarity and efficiency, helping them avoid costly delays and strengthen their regulatory submissions.

Understanding the Regulatory Framework

Biocompatibility evaluation sits at the intersection of science and regulation. Every manufacturer must begin by familiarizing themselves with the applicable framework in their target markets. The ISO 10993 series remains the global reference for biological evaluation, defining the principles and tests required to assess safety. In Europe, the Medical Device Regulation (MDR) adds strict requirements for documentation and justification, while the FDA applies ISO 10993 principles but often emphasizes device-specific considerations.

For Quality Managers and executives, knowing these requirements in advance is critical. It ensures that testing strategies are proportionate to the device’s risk profile, avoids redundant studies, and lays the groundwork for successful submissions across multiple markets.

The Role of Risk Assessment

According to ISO 10993-1 and ISO 14971, biological evaluation cannot be an isolated laboratory exercise—it must be part of a structured risk management process. This means preparing a Biological Evaluation Plan (BEP) that identifies risks, defines the rationale for specific tests, and explains where testing may be waived based on existing data.

A thorough risk assessment includes:

A detailed review of all device materials and components.
Consideration of manufacturing processes, sterilization, and additives.
Use of prior knowledge from similar devices or materials.

For decision-makers, this step provides clarity on where to allocate resources. Rather than approaching biocompatibility reactively, a well-structured risk assessment transforms it into a proactive, evidence-driven process.

Gathering Device Information

One of the most common reasons for delays in biocompatibility testing is incomplete or insufficient device information. To ensure smooth progress, manufacturers should prepare:

Device description: intended purpose, body contact site, duration of contact, physical characteristics such as surface area and shape.
Material details: complete lists of polymers, metals, coatings, adhesives, fillers, and colorants, including their specifications and grades.
Manufacturing details: process flow, sterilization methods, and any auxiliary substances like lubricants or cleaning agents.
Final configurations: all variants of the device intended for clinical use, to ensure that testing samples are representative.

For Quality Managers, this level of detail provides a clear link between design, production, and testing—a traceability chain that is indispensable during regulatory review.

Device Categorization and Contact Type

Biocompatibility testing requirements are determined not only by what a device is made of, but also by how it interacts with the body. ISO 10993 defines categories based on nature of contact (skin, mucosa, blood, or internal tissue) and duration of contact (limited <24 hours, prolonged up to 30 days, or permanent >30 days).

For example, a skin-contacting device used for minutes may only require cytotoxicity evaluation, or no laboratory testing at all, while an implantable device requires a much broader set of tests, including sensitization, irritation, and systemic toxicity. Recognizing this early helps manufacturers focus resources on the most relevant evaluations rather than pursuing unnecessary studies.

Supporting Documentation

Strong documentation is the backbone of a successful biocompatibility submission. Beyond test reports, regulators expect supporting evidence such as:

Material Safety Data Sheets (MSDS).
Previous test reports from identical or similar devices.
Extractables and leachables studies, particularly for devices with prolonged contact.
Sterilization validation reports, when sterilization impacts material safety.
Toxicological Risk Assessments (TRA), which integrate chemical and toxicological data into a comprehensive safety evaluation.

Providing these documents not only streamlines the testing process but also strengthens the scientific credibility of the submission.

Preparing Representative Samples

It is essential that samples submitted for testing reflect the final, sterilized, ready-to-use product. Submitting non-final or unsterilized devices risks invalidating results, leading to costly re-testing. Laboratories typically require sufficient quantities to perform the full scope of evaluations, so preparing production-equivalent samples in advance is a practical step to avoid delays.

Collaboration with Testing Laboratories

The most efficient manufacturers do not wait until the last moment to engage with a testing laboratory. Early collaboration enables:

Alignment of the testing plan with regulatory expectations.
Clarification of documentation and sample requirements.
Anticipation of potential challenges before they become critical issues.

From a leadership perspective, building a partnership with a reputable laboratory ensures not only scientific reliability but also strategic foresight. At EBI, we emphasize co-creation of testing strategies tailored to each device, allowing companies to save time and resources while maintaining compliance.

Common Challenges and How to Anticipate Them

Experience shows that many delays in biocompatibility testing are avoidable. Frequent challenges include:

Material changes after testing, which can invalidate results.
Incomplete documentation, delaying initiation of studies.
Underestimated timelines, as biocompatibility testing may take weeks or even months.

Awareness of these risks enables Quality Managers and CEOs to plan realistically, ensuring smoother development cycles.

Long-Term Perspective: Beyond Initial Approval

Biocompatibility does not end at product launch. Post-market surveillance, vigilance reporting, and reassessment after material or process changes are integral to maintaining compliance. Regulatory frameworks also continue to evolve, with increasing emphasis on animal-free alternatives and more advanced chemical characterization methods.

Forward-thinking leaders treat biocompatibility not as a one-time hurdle, but as an ongoing responsibility that underpins patient safety, brand reputation, and regulatory trust.

Conclusion

Biocompatibility testing requires more than laboratory expertise—it demands structured planning, strong documentation, and collaboration with experienced partners. For CEOs and Quality Managers, it represents a strategic investment that ensures patient safety, accelerates approval, and protects market reputation.

At EBI, we combine scientific knowledge with regulatory expertise to help manufacturers bring safe, compliant, and innovative devices to market—efficiently and confidently.

About the Author: Dr. Damian Matak

Dr. Damian Matak – an expert in medical device biocompatibility testing, serving as the CEO of ISO 17025-accredited and GLP-certified laboratories, including EBI – European Biomedical Institute and NABI – North American Biomedical Institute. As a member of the Polish Society of Toxicology and the I Local Ethical Committee, Dr. Matak contributes significantly to advancing safety standards in the biomedical field.